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AnteayerBMJ Open

Survival outcomes following complete mediastinal lymphadenectomy or selective mediastinal lymphadenectomy in patients with stage I-IIIA non-small cell lung cancer: protocol for a systematic review and meta-analysis

Por: Xu · J. · Lai · J. · Huang · X. · Ren · Y. · Chen · Q. · Li · W.
Introduction

Lung cancer remains the largest cause of cancer-related deaths worldwide. Surgical removal of non-small cell lung cancer (NSCLC) has the potential to achieve a cure, although there is ongoing debate regarding the significance of removing mediastinal nodes and the optimal extent of lymph node excision. The purpose of this research is to assess the survival outcomes in patients diagnosed with stage I–IIIA NSCLC who received either complete mediastinal lymphadenectomy (CML) or selective mediastinal lymphadenectomy (SML).

Methods and analysis

The protocol follows the guidelines recommended in Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols, and this meta-analysis will be conducted in accordance with the standard methodology recommended by the Cochrane Collaboration and reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 guidance. We will conduct a comprehensive search for randomised controlled trials and non-randomised studies examining the effectiveness of CML compared with SML in patients with stage I–IIIA NSCLC. Two authors will perform a comprehensive search of the MEDLINE/PubMed, Embase, the Cochrane Library, CNKI, WanFang, Sinomed, VIP and Web of Science databases. There will be no restrictions on language or publication date, and the search will be conducted on 10 April 2024, with ongoing searches for new research. Reference lists will also be checked and pertinent journals will be hand searched. The primary outcomes include overall survival (OS) and disease-free survival (DFS), while the secondary outcomes consist of 1-year, 3-year and 5-year OS rates and 1-year, 3-year and 5-year DFS rates. Two independent reviewers will screen, extract data, assess quality and evaluate the potential for bias in the selected research, with a third acting as arbitrator. Subgroup analyses and sensitivity analyses are planned. The quality of the evidence will be evaluated using Grading of Recommendations Assessment, Development and Evaluation. Review Manager V.5.4 will be used for the analysis and synthesis process.

Ethics and dissemination

Ethical review and approval are not necessary for this study because it is based on a secondary analysis of the literature. The results will be submitted for reporting in a peer-reviewed publication.

Study registration

Open Science Framework (https://doi.org/10.17605/OSF.IO/PN7UQ).

Home-based mobile-guided exercise-based cardiac rehabilitation among patients undergoing transcatheter aortic valve replacement (REHAB-TAVR): protocol for a randomised clinical trial

Por: Shen · Z. · Mi · S. · Huang · C. · Zhou · D. · Pan · W. · Xu · X. · Lin · Y. · Zhang · Y.
Introduction

Transcatheter aortic valve replacement (TAVR) is a standard treatment for aortic stenosis, particularly in older adults. Reduced exercise capacity and frailty significantly impact outcomes in TAVR patients, yet current management lacks strategies to address these issues. This study aims to assess the effectiveness of home-based mobile-guided exercise-based cardiac rehabilitation in TAVR patients, led by a multidisciplinary team with clear progression milestones.

Methods and analysis

The study involves 90 patients aged 60–89 in a single centre who will be randomised to a 3-month novel multidomain exercise intervention or routine care. Outcome assessors will be blinded towards group allocation. The primary outcome is the 6-min walk distance at month 3. The secondary outcomes include the 6-min walk distance at month 6, physical function measured by total Short Physical Performance Battery score and exercise adherence measured by the Exercise Adherence Rating Scale at months 3 and 6. Additional outcome measures, including rehospitalisations, death, handgrip strength, frailty (Fried Criteria and Essential Toolset), cognitive function (Mini-Mental State Examination), quality of life (EuroQol 5-Dimension 5-Level), nutritional status (Mini-Nutritional Assessment), anxiety (General Anxiety Disorder-7), depression (Geriatric Depression Scale), sleep (Pittsburgh Sleep Quality Index), functional capacity (Duke Activity Status Index), clinical indices (body mass index, symptoms, signs, left ventricular ejection fraction (LVEF), N-Terminal Pro-Brain Natriuretic Peptide, etc) and social support (Lubben Social Network Scale-6), along with comprehensive cost analysis, enhance the study’s significance. The study’s findings hold crucial implications for crafting an effective exercise-focused cardiac rehabilitation strategy for TAVR patients. Community implementation not only deepens understanding but also fosters the potential integration of exercise-based cardiac rehabilitation into self-care, promising enhanced patient adherence and overall cardiovascular health management.

Ethics and dissemination

Ethical approval was obtained from the Zhongshan Hospital, Fudan University Ethics Committee (B2022-062R). Results will be disseminated to local stakeholders and the research community through publications and conferences.

Trial registration number

NCT05989594

Effects of opioid-free anaesthesia compared with balanced general anaesthesia on nausea and vomiting after video-assisted thoracoscopic surgery: a single-centre randomised controlled trial

Por: Bao · R. · Zhang · W.-s. · Zha · Y.-f. · Zhao · Z.-z. · Huang · J. · Li · J.-l. · Wang · T. · Guo · Y. · Bian · J.-j. · Wang · J.-f.
Objectives

Opioid-free anaesthesia (OFA) has emerged as a promising approach for mitigating the adverse effects associated with opioids. The objective of this study was to evaluate the impact of OFA on postoperative nausea and vomiting (PONV) following video-assisted thoracic surgery.

Design

Single-centre randomised controlled trial.

Setting

Tertiary hospital in Shanghai, China.

Participants

Patients undergoing video-assisted thoracic surgery were recruited from September 2021 to June 2022.

Intervention

Patients were randomly allocated to OFA or traditional general anaesthesia with a 1:1 allocation ratio.

Primary and secondary outcome measures

The primary outcome measure was the incidence of PONV within 48 hours post-surgery, and the secondary outcomes included PONV severity, postoperative pain, haemodynamic changes during anaesthesia, and length of stay (LOS) in the recovery ward and hospital.

Results

A total of 86 and 88 patients were included in the OFA and control groups, respectively. Two patients were excluded because of severe adverse events including extreme bradycardia and epilepsy-like convulsion. The incidence and severity of PONV did not significantly differ between the two groups (29 patients (33.0%) in the control group and 22 patients (25.6%) in the OFA group; relative risk 0.78, 95% CI 0.49 to 1.23; p=0.285). Notably, the OFA approach used was associated with an increase in heart rate (89±17 vs 77±15 beats/min, t-test: p

Conclusions

Our study findings suggest that the implementation of OFA does not effectively reduce the incidence of PONV following thoracic surgery when compared with traditional total intravenous anaesthesia. The opioid-free strategy used in our study may be associated with severe adverse cardiovascular events.

Trial registration number

ChiCTR2100050738.

Interventional embolisation for patients with cirrhosis and recurrent or persistent hepatic encephalopathy related to spontaneous portosystemic shunts: protocol for a prospective, non-randomised controlled study

Por: Ke · Q. · Lin · T. · Lei · X. · Weng · X. · He · J. · Huang · X. · Li · L. · Guo · W.-H.
Introduction

The presence of spontaneous portosystemic shunts (SPSS) has been identified to be associated with hepatic encephalopathy (HE) in patients with cirrhosis. Nevertheless, the role of interventional embolisation in managing such patients remains poorly defined. Consequently, this prospective controlled study aims to assess the efficacy and safety of interventional embolisation as a therapeutic approach for patients with cirrhosis and recurrent or persistent HE related to SPSS.

Methods and analysis

Cirrhotic patients diagnosed with recurrent or persistent HE associated with SPSS will be recruited for this study, and assigned to either the interventional embolisation group or the standard medical treatment group. The efficacy endpoints encompass the evaluation of postoperative alleviation of HE symptoms and the incidence of overt HE recurrence during the follow-up period, as well as the duration and frequency of hospitalisations for HE, alterations in liver function and volume, and overall survival. The safety endpoints encompass both immediate and long-term postoperative complications.

Ethics and dissemination

This study will be conducted in strict adherence to the principles of good clinical practice and the guidelines outlined in the Declaration of Helsinki. Ethical approval for the trial has been obtained from the Ethics Committee of Mengchao Hepatobiliary Hospital of Fujian Medical University (2023_013_02). Written informed consent will be obtained from all the participants by the treating physician for each patient prior to their enrolment. The documented informed consent forms will be retained as part of the clinical trial records for future reference. The study findings will be disseminated through publication in peer-reviewed journals and will be presented at international conferences.

Trial registration number

ChiCTR2300072189.

Fruquintinib plus oxaliplatin combined with S-1 (SOX) as neoadjuvant therapy for locally advanced gastric cancer (GC) or gastro-oesophageal junction adenocarcinoma (GEJ): a multicentre, phase II, single-arm, open-label clinical trial (FRUTINEOGA) protocol

Por: Wu · L. · Yan · H. · Qin · Y. · Huang · M. · Wang · T. · Jin · Q. · Wei · W.
Introduction

Curing locally advanced gastric cancer (GC) or gastro-oesophageal junction adenocarcinoma (GEJ) with surgery alone is challenging. Neoadjuvant chemotherapy (NCT) has become the standard treatment for patients with locally advanced GC/GEJ, and SOX is the most common neoadjuvant regimen in China. The generally good tolerability in patients and fruquintinib’s low potential for drug–drug interaction suggest that it may be highly suitable for combinations with other antineoplastic therapies. A combination of fruquintinib, S-1 and oxaliplatin can be a promising neoadjuvant treatment for locally advanced GC/GEJ. In this phase II study, we aim to investigate the efficacy and toxicity of fruquintinib plus SOX as neoadjuvant treatment for locally advanced GC/GEJ.

Methods and analysis

The FRUTINEOGA trial is a prospective, multicentre, phase II, single-arm, open-label clinical trial that will enrol 54 patients. Eligible patients will be registered, enrolled and receive 2–4 cycles of fruquintinib plus SOX, after which surgery will be performed and tumour regression will be evaluated. The primary endpoint is the pathological remission rate, and the secondary endpoints are disease-free survival, overall survival, objective response rate, major pathological response rate and R0 resection rate.

Ethics and dissemination

Written informed consent will be required from all patients enrolled, and it will be provided by them. The study protocol received approval from the independent ethical review committee of Guangxi Medical University Cancer Hospital, Wuming Hospital of Guangxi Medical University and Wuzhou Red Cross Hospital, Wuzhou Gongren Hospital (approval number: CS2021(96)). We will submit the finalised paper for publication on completing the analyses. This study will provide valuable insights to clinicians regarding the safety and efficacy of incorporating fruquintinib into SOX as neoadjuvant treatment for locally advanced GC/GEJ. The findings have the potential to inform future research proposals and may guide the use of fruquintinib in the neoadjuvant setting for locally advanced GC/GEJ.

Trial registration number

NCT05122091.

Fertility policy changes, maternal and foetal characteristics and birth timing patterns at a tertiary referral centre in Beijing: a ten-year retrospective study

Por: Wang · D. · Wei · T. · Zhao · F. · Huang · J.
Objective

This study aimed to explore the impacts of the changing national fertility policy on maternal and fetal characteristics, and birth timing patterns and provide a basis for the management of the obstetric and midwifery workforce.

Design

Retrospective cohort study.

Setting

Data from medical register of a tertiary referral centre in Beijing, China.

Participants

We included 20 334 births with a gestational age more than 28 weeks during January 2013–September 2023.

Main outcomes

The main outcomes included birth numbers, maternal age, parity, birth modes, premature rates, neonatal birth weight, and birth timings.

Results

The birth rates showed a general rising trend before 2016. Afterwards, the birth rates kept decreasing and reached the bottom level in 2022. The caesarean section rates showed a declining trend, while the assisted birth rates were progressively rising, especially among primiparous women. From 2013 to 2022, the proportions of multiparous women (increasing from 9.3% to 36.6%) and women with advanced maternal age (increasing from 11.4% to 34.5%) were on the rise, together with increasing rates of premature birth (increasing from 5.7% to 8.5%) and neonatal low birth weight (rising from 4.3% to 7.2%) in this population. This study found a significant peak of births between 14:00 and 15:00, which remained unchanged despite shifts in the fertility policy (p values close to 1, respectively).

Conclusion

The ‘three-child’ policy did not boost the birth rate further 2 years later after its enactment, and the proportion of multiparous women and women with advanced maternal age were on the rise, accompanied by an increase in rates of premature birth and low birth weight. Targeted training should be offered to healthcare professionals to empower them to deal with possible negative pregnancy outcomes and childbirth complications. Prepregnancy and antepartum education should be parity specific. Adequate midwifery staffing during this 14:00–15:00 is vital to promote a safe birth.

Forecasting disease trajectories in critical illness: comparison of probabilistic dynamic systems to static models to predict patient status in the intensive care unit

Por: Duggal · A. · Scheraga · R. · Sacha · G. L. · Wang · X. · Huang · S. · Krishnan · S. · Siuba · M. T. · Torbic · H. · Dugar · S. · Mucha · S. · Veith · J. · Mireles-Cabodevila · E. · Bauer · S. R. · Kethireddy · S. · Vachharajani · V. · Dalton · J. E.
Objective

Conventional prediction models fail to integrate the constantly evolving nature of critical illness. Alternative modelling approaches to study dynamic changes in critical illness progression are needed. We compare static risk prediction models to dynamic probabilistic models in early critical illness.

Design

We developed models to simulate disease trajectories of critically ill COVID-19 patients across different disease states. Eighty per cent of cases were randomly assigned to a training and 20% of the cases were used as a validation cohort. Conventional risk prediction models were developed to analyse different disease states for critically ill patients for the first 7 days of intensive care unit (ICU) stay. Daily disease state transitions were modelled using a series of multivariable, multinomial logistic regression models. A probabilistic dynamic systems modelling approach was used to predict disease trajectory over the first 7 days of an ICU admission. Forecast accuracy was assessed and simulated patient clinical trajectories were developed through our algorithm.

Setting and participants

We retrospectively studied patients admitted to a Cleveland Clinic Healthcare System in Ohio, for the treatment of COVID-19 from March 2020 to December 2022.

Results

5241 patients were included in the analysis. For ICU days 2–7, the static (conventional) modelling approach, the accuracy of the models steadily decreased as a function of time, with area under the curve (AUC) for each health state below 0.8. But the dynamic forecasting approach improved its ability to predict as a function of time. AUC for the dynamic forecasting approach were all above 0.90 for ICU days 4–7 for all states.

Conclusion

We demonstrated that modelling critical care outcomes as a dynamic system improved the forecasting accuracy of the disease state. Our model accurately identified different disease conditions and trajectories, with a

Experiences and perspectives related to shared decision-making among outpatients with degenerative joint disease in Taiwan: a qualitative study

Por: Chuang · Y.-H. · Wang · C.-C. · Hsiao · C.-Y. · Lu · C.-Y. · Wu · J.-C. · Hou · W.-H.
Objectives

Various treatment options are available for degenerative joint disease (DJD). During clinical visits, patients and clinicians collaboratively make decisions regarding the optimal treatment for DJD; this is the essence of shared decision-making (SDM). Here, we collated and assessed the SDM-related experiences and perspectives of outpatients with DJD in Taiwan.

Design

In-depth interviews and thematic analysis.

Setting

Primary care clinics of a regional teaching hospital in Taiwan, October 2021–May 2022.

Participants

21 outpatients with at least three visits for DJD and who were aware of SDM.

Results

Four main themes emerged in this study: first, equipping themselves with knowledge: outpatients obtained disease-related and treatment-related knowledge in various ways—seeking relevant information online, discussing with family and friends, learning from their own experiences or learning from professionals. Second, shared or not shared: physicians had different patterns for communicating with patients, particularly when demonstrating authority, performing mutual discussion, respecting patient preferences or responding perfunctorily. Third, seldom saying no to physician-prescribed treatment plans during clinical visits: most patients respected physicians’ professionalism; however, some patients rejected physicians’ recommendations indirectly, whereas some responded depending on their disease prognosis. Fourth, whose call?—participants decided to accept or reject a treatment plan independently or by discussing it with their families or by obeying their physicians’ recommendations.

Conclusions

In general, patients with DJD sought reliable medical information from various sources before visiting doctors; however, when having a conversation with patients, physicians dominated the discussion on treatment options. The patient–physician interaction dynamics during the SDM process determined the final medical decision, which was in accordance with either patients’ original autonomy or physicians’ recommendations. To alleviate medical paternalism and physician dominance, patients should be empowered to engage in medical decision-making and share their opinions or concerns with their physicians. Family members should also be included in SDM.

Fibroids and unexplained infertility treatment with epigallocatechin gallate: a natural compound in green tea (FRIEND) - protocol for a randomised placebo-controlled US multicentre clinical trial of EGCG to improve fertility in women with uterine fibroids

Por: Al-Hendy · A. · Segars · J. H. · Taylor · H. S. · Gonzalez · F. · Siblini · H. · Zamah · M. · Alkelani · H. · Singh · B. · Flores · V. A. · Christman · G. M. · Johnson · J. J. · Huang · H. · Zhang · H.
Introduction

Uterine fibroids affect 30%–77% of reproductive-age women and are a significant cause of infertility. Surgical myomectomies can restore fertility, but they often have limited and temporary benefits, with postoperative complications such as adhesions negatively impacting fertility. Existing medical therapies, such as oral contraceptives, gonadotropin hormone-releasing hormone (GnRH) analogues and GnRH antagonists, can manage fibroid symptoms but are not fertility friendly. This study addresses the pressing need for non-hormonal, non-surgical treatment options for women with fibroids desiring pregnancy. Previous preclinical and clinical studies have shown that epigallocatechin gallate (EGCG) effectively reduces uterine fibroid size. We hypothesise that EGCG from green tea extract will shrink fibroids, enhance endometrial quality and increase pregnancy likelihood. To investigate this hypothesis, we initiated a National Institute of Child Health and Human Development Confirm-funded trial to assess EGCG’s efficacy in treating women with fibroids and unexplained infertility.

Methods and analysis

This multicentre, prospective, interventional, randomised, double-blinded clinical trial aims to enrol 200 participants with fibroids and unexplained infertility undergoing intrauterine insemination (IUI). Participants will be randomly assigned in a 3:1 ratio to two groups: green tea extract (1650 mg daily) or a matched placebo, combined with clomiphene citrate-induced ovarian stimulation and timed IUI for up to four cycles. EGCG constitutes approximately 45% of the green tea extract. The primary outcome is the cumulative live birth rate, with secondary outcomes including conception rate, time to conception, miscarriage rate, change in fibroid volume and symptom severity scores and health-related quality of life questionnaire scores.

Ethics and dissemination

The FRIEND trial received approval from the Food and Drug adminstration (FDA) (investigational new drug number 150951), the central Institutional Review Board (IRB) at Johns Hopkins University and FRIEND-collaborative site local IRBs. The data will be disseminated at major conferences, published in peer-reviewed journals and support a large-scale clinical trial.

Trial registration number

NCT05364008.

Effect of methylene blue on outcomes in patients with distributive shock: a meta-analysis of randomised controlled trials

Por: Huang · X. · Yan · W. · Chen · Z. · Qian · Y.
Objective

This meta-analysis aimed to demonstrate the effect of methylene blue (MB) in patients with distributive shock.

Design

Meta-analysis.

Methods

According to the Prospective International Register of Systematic Reviews (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, we searched the relevant randomised controlled trials (RCTs) via PubMed, Embase and Cochrane Library from the date of database inception to 19 April 2023. The primary outcome was mortality during follow-up, and secondary outcomes included mean arterial pressure (mm Hg), mechanical ventilation time (hours), intensive care unit (ICU) length of stay (LOS) (days), hospital LOS (days) and heart rate (times/min).

Results

This study included six RCTs with 265 participants. The study showed no significant difference in mortality between the MB and placebo groups (ORs: 0.59; 95% CI 0.32 to –1.06). However, MB reduced the duration of mechanical ventilation (mean difference (MD): –0.68; 95% CI –1.23 to –0.14), ICU LOS (MD: –1.54; 95% CI –2.61 to –0.48) and hospital LOS (MD: –1.97; 95% CI –3.92 to –0.11).

Conclusions

The use of MB may not reduce mortality in patients with distributive shock, but may shorten the duration of mechanical ventilation, ICU LOS and hospital LOS. More clinical studies are needed to confirm these findings in the future.

Trial registration number

CRD42023415938.

Epidemiological characteristics of suspected adenomyosis in the Chinese physical examination population: a nested case-control study

Por: Huang · Y. · Su · X. · Chen · K. · Zhang · L. · Xu · W. · Pu · Y. · Xu · F. · Gong · R. · Zhang · J. · Nie · Y. · Shi · Q.
Objectives

We aimed to explore the epidemiological characteristics of suspected adenomyosis within a physical examination population in China.

Design

A retrospective, nested case-control study; we matched healthy people and those with potential adenomyosis on a 1:2 ratio by age.

Setting

A tertiary hospital health management centre.

Participants

We included 15–60 years old women who underwent at least one uterine examination from October 2017 to December 2020, excluding those who had undergone hysterectomy and menopause.

Primary and secondary outcome measures

We estimated the incidence and prevalence rate of suspected adenomyosis. Conditional logistic regression was used to estimate associations between serum biomarkers and potential adenomyosis. Areas under the receiver-operating characteristic curves (AUC) were used to determine the cut-off point of the cancer antigen 125 (CA125) level for suspected adenomyosis.

Results

A total of 30 629 women had uterus-related imaging examinations; 877 had suspected adenomyosis. The standardised incidence and prevalence of suspected adenomyosis was 1.32% and 2.35%, respectively, for all age groups. The conditional logistic regression analysis results showed that total bilirubin≥18.81 µmol/L (HR: 2.129; 95% CI 1.067 to 4.249; p24 kg/m2 (HR: 1.262; 95% CI 1.055 to 1.511; p

Conclusions

The disease burden of suspected adenomyosis remains huge and can be informed by biomarkers. The disease-specific threshold of CA125 will support further preventive strategy development in population.

Trial registration number

ChiCTR2100049520, 2021/8/2.

Risk factors and glycaemic control in small-for-gestational-age infants born to mothers with gestational diabetes mellitus: a case-control study using propensity score matching based on a large population

Por: Li · J. · Pan · Y. · Zheng · Q. · Chen · X. · Jiang · X. · Liu · R. · Zhu · Y. · Huang · L.
Background

Small for gestational age (SGA) poses a significant concern for newborns, being linked to neonatal complications and potential metabolic disorders in adulthood, especially when born to mothers with gestational diabetes mellitus (GDM), elevating their risk of complications and mortality. However, the pregnancy risk factors and glycaemic control associated with SGA infants born to mothers with GDM remain unclear.

Aim

To identify the pregnancy risk factors and glycaemic control associated with SGA infants born to mothers with GDM.

Method

This case–control study was conducted among 1910 women with GDM in China. Data were collected by the integrated electronic medical record system. Using 1:4 propensity score matching analysis, we adjusted for gestational age as confounder. Univariate and multivariate analyses were performed to identify risk factors.

Results

Risk factors for SGA born to mothers with GDM included a history of low birth weight, gestational hypertension, oligohydramnios, short maternal height, underweight pre-pregnancy body mass index and inadequate weight growth. While SGA was protected by weakly positive ketonuria levels in the first trimester, multiparous, anaemia and previous uterine scar were protective factors for SGA. Moreover, 2-hour postprandial glucose and haemoglobin A1c in the second trimester, as well as the 0-hour and 2-hour 75 g oral glucose tolerance test (OGTT) were linked to risk of SGA.

Conclusions

SGA infants are the result of multifactorial interactions among GDM pregnant women. Notably, glycaemic control levels were associated with SGA. There is a need for enhanced perinatal monitoring and antenatal care to reduce SGA.

Characterising respiratory infections among hospitalised children during the COVID-19 pandemic in southeastern China: a cross-sectional study of pathogens and clinical association

Por: Huang · H. · Wu · B. · Lin · W.
Objective

Children with acute respiratory tract infections (ARTIs) pose significantly burden on healthcare facilities due to high hospitalisation rates and mortality. However, limited epidemiological and clinical characteristics data on ARTIs in southeastern China during the COVID-19 pandemic exists.

Design

Cross-sectional.

Setting

Tertiary hospital associated with the First Affiliated Hospital, Fujian Medical University, China.

Participants

1007 hospitalised children diagnosed with ARTIs, aged 30 days to 15 years, were enrolled in this study from 1 January 2020 to 31 December 2021.

Outcome measure

The primary outcomes are the rate of pathogen infections in children with ARTIs. Secondary outcomes are the description of risk factors associated with ARTIs in children.

Results

Of the 1007 enrolled children, 28.2%, 42.2%, 21.8% and 7.7% were diagnosed with upper respiratory tract infection, bronchopneumonia, bronchitis and pneumonia, respectively. Mycoplasma pneumoniae (MP) was the most prevalent pathogen (31.9%), followed by influenza B virus (IFVB; 29.1%) and influenza A virus (IFVA; 19.1%). The study found that children under 1 year old (older than 30 days: ORIFVB=12.50; ORMP=8.53), children aged 1–3 years (ORMP=1.62), the winter season (ORIFVA=1.36), the time from symptoms onset to hospitalisation (ORMP=1.10) and increased precipitation (ORLP=1.01) were high-risk factors for ARTIs.

Conclusion

This investigation offers significant insights into the prevalence and distribution of common pathogens among children experiencing ARTIs in the context of the COVID-19 pandemic. The discernment of high-risk factors linked to these pathogens enhances our understanding of the epidemiological characteristics of ARTIs in children.

Effect of extracorporeal shock wave combined with Kinesio taping on upper limb function during individuals with biceps brachii tendinopathy:protocol for a double-blind, randomised controlled trial

Por: Liu · K. · Yin · L. · Zhang · Y. · Huang · L. · Liu · G. · Zhu · R. · Fang · P. · Ma · Y. · Ma · Z.
Introduction

Long head of biceps brachii tendinopathy (LHBT) is characterised by persistent pain and disability of shoulder joint, impairing patients’ quality of life. Extracorporeal shock wave therapy (ESWT) is a non-invasive treatment, which promotes tissue regeneration and repair. However, ESWT has a side effect that often causes short-term pain and swelling in the treatment area. It is known that the effects of Kinesio taping (KT) on relieving swelling and pain. Due to insufficient clinical evidence from current limited studies, this randomised controlled study aims to explore the effects of ESWT combined with KT on upper limb function during individuals with LHBT.

Methods and analysis

A 2x2 factorial design, double-blind, randomised controlled trial will be conducted. A total of 144 participants will be randomly allocated into one of four groups (KT+ESWT, KT+sham ESWT, sham KT+ESWT or sham KT+sham ESWT) to participate in a 4-week treatment programme. Measurements will be taken at pretreatment (baseline), immediately after treatment and 6 weeks after treatment. The primary endpoint will be the Constant-Murley score (CMS), the secondary endpoints will include the pain Numerical Rating Scale, range of motion, pressure pain threshold and soft tissue hardness of biceps, speed test and global rating of change. Repeated measures analysis of variance will be used to compare differences among the effects of different interventions.

Ethics and dissemination

Ethics approval was obtained from the Ethics Committee of the Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine. In addition to international conference reports, findings will be disseminated through international publications in peer-reviewed journals.

Trial registration number

ChiCTR2100051324.

Changing epidemiology, microbiology and mortality of bloodstream infections in patients with haematological malignancies before and during SARS-CoV-2 pandemic: a retrospective cohort study

Por: Cai · L. · Chen · H. · Wei · Y. · Guo · X. · Zheng · H. · Jiang · X. · Zhang · Y. · Yu · G. · Dai · M. · Ye · J. · Zhou · H. · Xu · D. · Huang · F. · Fan · Z. · Xu · N. · Shi · P. · Xuan · L. · Feng · R. · Liu · X. · Sun · J. · Liu · Q. · Wei · X.
Objective

This study was to explore the changes in bacterial bloodstream infection (BSI) in patients with haematological malignancies (HMs) before and during SARS-CoV-2 pandemic.

Design

Retrospective cohort study between 2018 and 2021.

Setting

The largest haematological centre in southern China.

Results

A total of 599 episodes of BSI occurring in 22 717 inpatients from January 2018 to December 2021 were analysed. The frequencies of the total, Gram-negative and Gram-positive BSI before and during the pandemic were 2.90% versus 2.35% (p=0.011), 2.49% versus 1.77% (p

Conclusion

Our data showed that the incidence of total and Gram-negative organisms BSI decreased, but Gram-positive BSI incidence increased in patients with HMs during the pandemic along with the changes of main isolates and susceptibility profiles. Although the 30-day mortality due to BSI was lower during the pandemic, the new infection prevention strategy should be considered for any future pandemics.

Association between the number of retrieved lymph nodes and demographic/tumour-related characteristics in colorectal cancer: a systematic review and meta-analysis

Por: Liu · Q. · Huang · M. · Yang · J. · Jiang · M. · Zhao · Z. · Zhao · H. · He · T. · Bai · Y. · Zhang · R. · Zhang · M.
Objective

Clinical practice guidelines recommend retrieving at least 12 lymph nodes for correct staging in colorectal cancer. However, it is difficult to retrieve adequate lymph nodes because of various factors. We aimed to evaluate the association between the number of retrieved lymph nodes and demographic/tumour-related characteristics in colorectal cancer.

Design

Systematic review and meta-analysis of primary studies.

Data sources

PubMed, Embase, Cochrane and Web of Science were searched from January 2016 to June 2023.

Eligibility criteria for selecting studies

Studies that evaluated the association between retrieved lymph nodes and demographic/tumour-related characteristics in colorectal cancer were included.

Data extraction and synthesis

OR with 95% conference intervals was extracted and pooled.

Results

A total of 54 studies containing 2 05 821 patients were included in this meta-analysis. The results showed that fewer nodes were retrieved from elderly patients (OR=0.70, 95% CI (0.54 to 0.90), p=0.005), and from tumours located in the left colon than in the right colon (OR=0.43, 95% CI (0.33 to 0.56), p

Conclusions

The study results suggest that clinicians have an increased opportunity to retrieve sufficient lymph nodes for accurate pathological staging to guide treatment decisions in patients with colorectal cancer who are young, female, with tumours located in the right colon, advanced T stage and N2 stage.

Nationwide survey of physicians familiarity and awareness of diabetes guidelines in China: a cross-sectional study

Por: Jia · L.-y. · Huang · C.-x. · Zhao · N.-j. · Lai · B.-y. · Zhang · Z.-h. · Li · L. · Zhan · N. · Lin · Y.-b. · Cai · M.-n. · Wang · S.-q. · Yan · B. · Liu · J.-p. · Yang · S.-y.
Objective

This study aims to investigate physicians’ familiarity and awareness of four diabetes guidelines and their practice of the recommendations outlined in these guidelines.

Design

A cross-sectional study.

Setting

An online questionnaire survey was conducted among physicians affiliated with the Specialist Committee for Primary Diabetes Care of China Association of Chinese Medicine, using the snowball sampling method to ensure a broader representation of physicians.

Participants

1150 physicians from 192 cities across 30 provinces in China provided complete data.

Results

Tertiary care hospital physicians (TCPs) exhibited the highest familiarity with the Guideline for the Prevention and Treatment of Type 2 Diabetes Mellitus in China (91.3%), followed by the National Guidelines for the Prevention and Control of Diabetes in Primary Care (76.8%), the Standards of Medical Care in Diabetes (72.2%) and the Guidelines for Prevention and Treatment of Diabetes in Chinese Medicine (63.8%). Primary care practitioners (PCPs) exhibited familiarity with these four guidelines at about 50% or less. Self-reported reference to modern diabetes guidelines by physicians is more frequent than traditional Chinese medicine (TCM) diabetes guidelines, with rates at 73.2% and 33.8%, respectively. Approximately 90% of physicians provided instructions on self-monitoring of blood glucose to their patients with diabetes. Less than one-third of physicians referred patients to a specialised nutritionist. In terms of health education management, TCPs reported having a diabetes health management team at the rate of 75.7%, followed by secondary care hospital physicians at 57.0% and PCPs at 27.5%. Furthermore, approximately 40% of physicians did not fully grasp hypoglycaemia characteristics.

Conclusions

Familiarity and awareness of the screening guidelines varied among physicians in different hospital settings. Importantly, significant discrepancies were observed between physicians’ awareness and their self-reported reference to modern medicine guidelines and TCM guidelines. It is essential to consistently provide education and training on diabetes management for all physicians, particularly PCPs.

Establishment and validation of a prediction model for myocarditis in Chinese children below 14 years old: a protocol for a retrospective cohort study

Por: Wu · L. · Ji · W. · Huang · Y. · Zeng · H. · Chen · J. · Zou · Y. · Lin · W. · Lin · Y.
Introduction

Paediatric myocarditis, a rare inflammatory disease, often presents without clear early symptoms. Although cardiac troponin I levels can aid in diagnosing myocarditis, they are not definitive indicators. Troponin I levels frequently fluctuate within and outside the reference range, potentially causing misinterpretations by clinicians. Although a negative troponin I result is valuable for excluding myocarditis, its specificity is low. Moreover, the clinical diagnosis of paediatric myocarditis is exceptionally challenging, and accurate early-stage diagnosis and treatment pose difficulties. Currently, the Dallas criteria, involving cardiac biopsy, serves as the gold standard for myocarditis diagnosis. However, this method has several drawbacks and is unsuitable for children, resulting in its limited use.

Methods and analysis

In this study, we will employ multiple logistic regression analysis to develop a predictive model for early childhood myocarditis. This model will assess the patient’s condition at onset and provide the probability of a myocarditis diagnosis. Model performance will be evaluated for accuracy and calibration, and the results will be presented through receiver operating characteristic (ROC) curves and calibration plots. Clinical decision curve analysis, in conjunction with ROC curve analysis, will be employed to determine the optimal cut-off value and calculate the net clinical benefit value for assessing clinical effectiveness. Finally, internal model validation will be conducted using bootstrapping.

Ethics and dissemination

Approval from the Clinical Research Ethics Committee of The Third Affiliated Hospital of Wenzhou Medical University has been obtained. The research findings will be disseminated through presentations at scientific conferences and publication in peer-reviewed journals.

Non-high-density lipoprotein cholesterol levels as a risk factor for short-term mortality in elderly Chinese: a large-scale, population-based cohort study

Por: Xiao · W. · Liu · S. · Huang · Z. · Jin · D. · Yang · Y. · Li · F. · Duan · J. · Wang · J. · Li · Y. · Deng · P. · Wang · W. · Meng · C. · Wu · J. · Cai · J. · Li · Y. · Hong · Y.
Objectives

To explore the association between non-high-density lipoprotein (non-HDL) and mortality risk, both short-term and long-term, in Chinese people.

Design

A prospective cohort study.

Setting

The National Basic Public Health Service (BPHS) in China.

Participants

Including 621 164 elderly individuals around Hunan Province who underwent healthcare management receiving check-ups in China BPHS from 2010 to 2020. Exclusion criteria: (1) missing information on gender; (2) missing records of lipid screening; (3) missing information on key covariates; and (4) missing records of comorbidities (cardiovascular disease, hypertension, diabetes, cancer.)

Primary and secondary outcome measures

The study’s primary endpoint was all-cause and cause-specific mortality, sourced from Hunan’s CDC(Center for Disease Control and Prevention)-operated National Mortality Surveillance System, tracking participants until 24 February 2021.

Results

26 758 (4.3%) deaths were recorded, with a median follow-up of 0.83 years. Association between non-HDL and mortality was non-linear after multivariable adjustment, with the optimum concentration (OC) being 3.29 and 4.85 mmol/L. Compared with OC, the risk increased by 1.12-fold for non-HDL for non-HDL : 1.10 (1.06 to 1.32) and HR for non-HDL ≥4.85: 1.07 (1.01 to 1.14)). However, cancer mortality risk was significantly increased only for non-HDL

Conclusions

Non-HDL was non-linearly associated with the risk of mortality, and non-optimal concentrations of non-HDL significantly increased short-term mortality in elderly Chinese, which needs more attention for cardiovascular disease prevention.

Comparing the efficacies of transcranial magnetic stimulation treatments using different targeting methods in major depressive disorder: protocol for a network meta-analysis

Por: Wang · S. · Kong · G. · Wu · G. · Cui · H. · Qian · Z. · Xu · L. · Wei · Y. · Wang · J. · Huang · J. · Wang · J. · Li · H. · Tang · Y.
Introduction

Transcranial magnetic stimulation (TMS) over the left dorsolateral prefrontal cortex (lDLPFC) has been widely used as a treatment for major depressive disorder (MDD) in the past two decades. Different methods for localising the lDLPFC target include the ‘5 cm’ method, the F3 method and the neuro-navigational method. However, whether TMS efficacies differ between the three targeting methods remains unclear. We present a protocol for a systematic review and network meta-analysis (NMA) to compare the efficacies of TMS treatments using these three targeting methods in MDD.

Methods and analysis

Relevant studies reported in English or Chinese and published up to May 2023 will be identified from searches of the following databases: PubMed, Cochrane Central Register of Controlled Trials, Embase, PsycINFO, China National Knowledge Infrastructure, Wan Fang Database, Chinese BioMedical Literature Database, and China Science and Technology Journal Database. We will include all randomised controlled trials assessing the efficacy of an active TMS treatment using any one of the three targeting methods compared with sham TMS treatment or comparing efficacies between active TMS treatments using different targeting methods. Interventions must include a minimum of 10 sessions of high-frequency TMS over the lDLPFC. The primary outcome is the reduction score of the 17-item Hamilton Depression Rating Scale, 24-item Hamilton Depression Rating Scale or Montgomery-Asberg Depression Rating Scale. The dropout rate is a secondary outcome representing the TMS treatment’s acceptability. Pairwise meta-analyses and a random-effects NMA will be conducted using Stata. We will use the surface under the cumulative ranking curve to rank the different targeting methods in terms of efficacy and acceptability.

Ethics and dissemination

This systematic review and NMA does not require ethics approval. The results will be submitted for publication in a peer-reviewed journal.

PROSPERO registration number

CRD42023410273.

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